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NCT Number: NCT07696767

Efficacy and Safety of MegaLT Injection for Platelet Recovery After Umbilical Cord Blood Transplantation

This is a single-arm, early safety and feasibility exploratory study to evaluate the efficacy and safety of MegaLT Injection in promoting platelet recovery after umbilical cord blood transplantation. Adults with malignant hematologic diseases who undergo umbilical cord blood transplantation will receive a single intravenous infusion of MegaLT Injection on day 14 after transplantation. Two dose levels will be evaluated sequentially, and platelet recovery, platelet transfusion requirements, and safety outcomes will be assessed.

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Key information

Conditions

Thrombocytopenia Blood Platelet Disorders Cytopenia Hematologic Diseases Hematologic Malignacies Hemic and Lymphatic Diseases Platelet Recovery After Umbilical Cord Blood Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

About this study

This study is designed as a single-arm, early safety and feasibility exploratory study of MegaLT Injection in patients undergoing umbilical cord blood transplantation. Eligible participants will receive MegaLT Injection by intravenous infusion on day 14 after transplantation. The study includes two sequential dose levels: 1×10^6/kg and 2.5×10^6/kg. Three participants are planned for each dose level, with a total planned enrollment of 7 participants after accounting for an approximately 10% dropout rate. The study will evaluate platelet engraftment, platelet recovery, platelet transfusion requirements, hematopoietic recovery, and safety outcomes including adverse events, bleeding events, thromboembolic events, graft-versus-host disease, and transplant-related mortality.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years, male or female.
  • Patients with a definite diagnosis of hematologic malignancy who are undergoing umbilical cord blood transplantation.
  • Patients at day 14 after umbilical cord blood transplantation.
  • ECOG performance status ≤2.
  • Patients who voluntarily agree to participate in this clinical trial, fully understand the study content, and sign the informed consent form.

Exclusion criteria

  • Patients with relapse of any malignant tumor.
  • Pregnant or lactating women.
  • Patients with severe infection or severe cardiac, hepatic, pulmonary, renal, neurologic, or metabolic disease.
  • Patients with a history of severe thrombotic events or known risk factors for thrombosis. Exception: participants for whom the investigator determines that the potential benefit of study participation outweighs the potential risk of thromboembolic events.
  • Patients with uncontrolled infectious disease or other serious diseases, including but not limited to infection such as HIV positivity, congestive heart failure, unstable angina, cardiac arrhythmia, psychosis, social circumstances that would limit compliance with study requirements, or any condition that the treating physician considers may pose unpredictable risks.
  • Patients with active hepatitis B or hepatitis C.
  • Patients who have previously received organ transplantation or are planning to receive organ transplantation, except for hematopoietic stem cell transplantation.
  • Patients who participated in another clinical study and used any investigational drug or device within 30 days before the baseline visit. Participation in observational studies is allowed.
  • Patients considered by the investigator to be unsuitable for participation in this clinical trial for any other reason.

Treatment and study plan

MegaLT injection

Biological

MegaLT Injection is prepared from eligible umbilical cord blood cells through directed expansion and quality control to obtain a megakaryocyte cell product. Participants will receive MegaLT Injection by intravenous infusion on day 14 after umbilical cord blood transplantation. The assigned dose will be 1×10^6/kg or 2.5×10^6/kg, with sequential dose escalation from the low-dose level to the high-dose level. Each participant will receive one assigned cell dose; multiple infusions may be considered if necessary according to the protocol.

Primary outcomes

  1. Time to Platelet Engraftment

    Time frame: From umbilical cord blood transplantation until documented platelet engraftment or the participant's last platelet assessment, assessed up to 6 months following MegaLT infusion.

    Platelet engraftment is defined as the first day of 7 consecutive days with platelet count ≥20×10^9/L without platelet transfusion.

  2. Platelet Engraftment by Day 28

    Time frame: At day 28 after umbilical cord blood transplantation

    Cumulative incidence of platelet engraftment by day 28 after transplantation, defined as 7 consecutive days with platelet count ≥20×10^9/L without platelet transfusion.

Secondary outcomes

  1. Platelet Recovery by Day 28

    Time frame: At day 28 after umbilical cord blood transplantation

    Cumulative rate of platelet recovery by day 28 after transplantation, defined as platelet count ≥50×10^9/L for 7 consecutive days without platelet transfusion.

  2. Time to Platelet Count Thresholds

    Time frame: From umbilical cord blood transplantation until documented platelet count recovery at each threshold or the participant's last platelet assessment, assessed up to 6 months following MegaLT infusion.

    Median time to achieve platelet counts of ≥20×10^9/L, ≥50×10^9/L, and ≥100×10^9/L without platelet transfusion.

  3. Platelet Transfusion Volume

    Time frame: From MegaLT Injection to 4 weeks after injection

    Total amount of platelet transfusion received by participants within 4 weeks after MegaLT Injection.

  4. Neutrophil Engraftment by Day 28

    Time frame: At day 28 after umbilical cord blood transplantation

    Cumulative incidence of neutrophil engraftment by day 28 after transplantation, defined as an absolute neutrophil count ≥0.5×10^9/L for 3 consecutive days.

  5. Megakaryocyte Level in Bone Marrow

    Time frame: At 4 weeks after MegaLT Injection

    Megakaryocyte level assessed by bone marrow smear 4 weeks after MegaLT Injection.

Other outcomes

  1. Adverse Events

    Time frame: From MegaLT Injection to 6 months after injection

    Incidence of adverse events after MegaLT Injection, including clinical symptoms and laboratory abnormalities. Adverse events will be assessed according to the Common Terminology Criteria for Adverse Events version 5.0 when applicable.

  2. Bleeding Events

    Time frame: From MegaLT Injection to 6 months after injection

    Incidence of bleeding events after MegaLT Injection, assessed using the WHO bleeding assessment scale.

  3. Transplant-Related Complications and Mortality

    Time frame: From umbilical cord blood transplantation to 100 days after transplantation

    Incidence of transplant-related complications and transplant-related mortality within 100 days after umbilical cord blood transplantation.

  4. Graft-Versus-Host Disease

    Time frame: From MegaLT Injection to 6 months after injection

    Incidence and severity of acute graft-versus-host disease and chronic graft-versus-host disease after MegaLT Injection.

  5. Severe GVHD-Free, Relapse-Free Survival

    Time frame: From MegaLT Injection to 6 months after injection

    Survival without severe graft-versus-host disease or relapse after MegaLT Injection.

  6. Thromboembolic Events

    Time frame: From MegaLT Injection to 6 months after injection

    Incidence and severity of thromboembolic events after MegaLT Injection, including deep vein thrombosis and pulmonary embolism. Relevant indicators such as D-dimer will be dynamically monitored.

Study contacts

Contact information is provided by the study sponsor or research team.

Aijie Huang, MD

CONTACT

[email protected]

Xiaoyu Zhu, MD, PhD

CONTACT

[email protected]

+86-551-62282931

Sponsors and collaborators

Lead sponsor

Anhui Provincial Hospital

Other Gov

Registry information

Official study title

Study of the Efficacy and Safety of MegaLT Injection for Promoting Platelet Recovery After Umbilical Cord Blood Transplantation

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 10, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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